CELL & GENE THERAPY INSIGHTS

Raw and Starting Materials

Guest Editor:
Rob Piperno, Director, Cell & Gene Therapy Quality Assurance at GlaxoSmithKline
Rob Piperno
Director, Cell & Gene Therapy Quality Assurance at GlaxoSmithKline
<p>Robert G Piperno is the Director of CGT Quality Assurance in the Global Pharma QA organization. In this role he is responsible for providing the global quality oversight and management of internal and external activities supporting clinical and commercial Cell and Gene Therapy Products, including the approval of STRIMVELIS&trade; by EMA. Rob joined GSK in 2009 as part of the Corporate Audit and Assurance function and transitioned to R&amp;D QA in 2012, and to CGT QA in 2014. He has over 20 years of experience in the pharmaceutical industry and prior to GSK he was employed at Johnson &amp; Johnson for 9 years holding positions including, site quality operations and leading a corporate team supporting the management of external partners and CMOs. Rob has a Bachelor&rsquo;s and Master&rsquo;s degree in Biology from Rutgers University and an MBA in Pharmaceutical Management from St. Joseph&rsquo;s University.</p>
February 2019

  • Tackling the critical issues pertaining to raw & starting materials for cell & gene therapy manufacturing

    Tackling the critical issues pertaining to raw & starting materials for cell & gene therapy manufacturing

    7 May 2019
    Expert Roundtable
    Richard McFarland,
    Richard McFarland
    Chief Regulatory Officer at Advanced Regenerative Manufacturing Institute
    Richard McFarland, PhD, MD, joined ARMI as its Chief Regulatory Officer in May 2018 having been at the Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA/CBER) where his career of over 16 years involved review of an extensive range of products and policy development in numerous areas inside FDA, across the federal government, and internationally. He spent almost two decades at the FDA, including time as Associate Director of Policy for FDA/CBER’s Office of Tissues and Advanced Therapies (OTAT), and its predecessor office, the Office of Cellular, Tissue and Gene Therapies (OCTGT).
    Ivar Kljavin,
    Ivar Kljavin
    Head of Quality, Bioproduction Division at Thermo Fisher Scientific
    Ivar joined Thermo Fisher in January 2018 having spent 24 years in the pharmaceutical industry with Roche – five years in research and the rest in Global Quality roles, QC/QA. What drew him to the Thermo Fisher role is the opportunity to influence the future state of supply of medicine to patients. Ivar is passionate about the transition of Thermo Fisher’s quality system – and the need to integrate Quality process and goals with customers so that we are aligned with the mission of insuring supply of medicine to patients. Thermo Fisher definitely has the capability to make this happen.
    Timothy Moore
    Timothy Moore
    Tim Moore has more than three decades of leadership experience in biopharmaceutical manufacturing and operations. Most recently, he served as Senior Vice President, Head of Global Technical Operations – Biologics of Genentech, Inc. and as a member of the Genentech Executive Committee since 2010. In this role, Mr. Moore oversaw global leadership for more than 7,500 professionals across 10 internal sites and over 37 contract manufacturing organizations, as well as global manufacturing and end-to-end quality supply performance of more than 20 biological product families. Prior to that, Mr. Moore was Genentech’s Senior Vice President, Global Supply Chain and Global Engineering from 2007 to 2010. Previously, Mr. Moore served as Vice President, Operations at ZLB Behring (formerly Aventis Behring). He is currently a member of the Executive Committee of BioPhorum Operations Group (BPOG) and the Manufacturing Leadership Council. Mr. Moore received a B.S. in Chemical Engineering from Tulsa University and a M.S. in Engineering Management from Northwestern University.
  • Tackling the critical issues pertaining to raw & starting materials for cell & gene therapy manufacturing

    R McFarland,
    Richard McFarland
    Chief Regulatory Officer at Advanced Regenerative Manufacturing Institute
    Richard McFarland, PhD, MD, joined ARMI as its Chief Regulatory Officer in May 2018 having been at the Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA/CBER) where his career of over 16 years involved review of an extensive range of products and policy development in numerous areas inside FDA, across the federal government, and internationally. He spent almost two decades at the FDA, including time as Associate Director of Policy for FDA/CBER’s Office of Tissues and Advanced Therapies (OTAT), and its predecessor office, the Office of Cellular, Tissue and Gene Therapies (OCTGT).
    I Kljavin,
    Ivar Kljavin
    Head of Quality, Bioproduction Division at Thermo Fisher Scientific
    Ivar joined Thermo Fisher in January 2018 having spent 24 years in the pharmaceutical industry with Roche – five years in research and the rest in Global Quality roles, QC/QA. What drew him to the Thermo Fisher role is the opportunity to influence the future state of supply of medicine to patients. Ivar is passionate about the transition of Thermo Fisher’s quality system – and the need to integrate Quality process and goals with customers so that we are aligned with the mission of insuring supply of medicine to patients. Thermo Fisher definitely has the capability to make this happen.
    T Moore
    Timothy Moore
    Tim Moore has more than three decades of leadership experience in biopharmaceutical manufacturing and operations. Most recently, he served as Senior Vice President, Head of Global Technical Operations – Biologics of Genentech, Inc. and as a member of the Genentech Executive Committee since 2010. In this role, Mr. Moore oversaw global leadership for more than 7,500 professionals across 10 internal sites and over 37 contract manufacturing organizations, as well as global manufacturing and end-to-end quality supply performance of more than 20 biological product families. Prior to that, Mr. Moore was Genentech’s Senior Vice President, Global Supply Chain and Global Engineering from 2007 to 2010. Previously, Mr. Moore served as Vice President, Operations at ZLB Behring (formerly Aventis Behring). He is currently a member of the Executive Committee of BioPhorum Operations Group (BPOG) and the Manufacturing Leadership Council. Mr. Moore received a B.S. in Chemical Engineering from Tulsa University and a M.S. in Engineering Management from Northwestern University.
    7 May 2019
    Expert Roundtable
  • Making an efficient & effective transition to GMP raw materials

    U Nirenberg
    Udo Nirenberg
    Head, Quality Management at CellGenix GmbH
    Dr Udo Nirenberg is Vice President of Quality Management at CellGenix, where he is responsible for the quality system of CellGenix and the quality of the products. Udo has more than 25 years experience in the industry in leading positions in Quality Control, Quality Assurance as well as Regulatory Affairs. Udo holds a degree in chemistry and received his Ph.D. in analytical chemistry from the University of Frankfurt/Main, Germany. He started his carreear at Bachem, Switzerland, a leading GMP manufacturerer of peptides. In the following years he took over the responsibilities for quality control, quality assurance and regulatory affairs departments at Bachem affiliates in the United States. Prior to his position at CellGenix, Udo was responsible for quality control testing of biopharmaceuticals under GMP and quality management for more than 10 years at Solvias AG, a globally acting analytical contract laboratory in Switzerland. Quality Management at CellGenix, where he is responsible for the quality system of CellGenix and the quality of the products. Udo has more than 25 years experience in the industry in leading positions in Quality Control, Quality Assurance as well as Regulatory Affairs. Udo holds a degree in chemistry and received his Ph.D. in analytical chemistry from the University of Frankfurt/Main, Germany. He started his carreear at Bachem, Switzerland, a leading GMP manufacturerer of peptides. In the following years he took over the responsibilities for quality control, quality assurance and regulatory affairs departments at Bachem affiliates in the United States. Prior to his position at CellGenix, Udo was responsible for quality control testing of biopharmaceuticals under GMP and quality management for more than 10 years at Solvias AG, a globally acting analytical contract laboratory in Switzerland.
    24 April 2019
    Interview
  • Managing starting material stability to maximize manufacturing flexibility and downstream efficiency

    D Clarke,
    Dominic Clarke
    Global Head of Cell Therapy at HemaCare Corporation
    Dr. Clarke has over 15 years of experience developing enabling solutions to support cell and gene therapies. He is the Global Head of Cell Therapy at HemaCare, a leading provider of source material for clinical development and commercial manufacturing of cell-based therapies. Previous roles include, Global Product Manager for Charter Medical’s cell therapy and bioprocessing single-use systems portfolio and Director of Research and Development for BioLife Solutions.Dominic currently serves as the co-chair for the International Society for Cell and Gene Therapies Process and Product Development Committee with efforts directed towards translating research and process development from bench to clinic.
    D Smith
    David Smith
    Senior Biomedical Engineer at Hitachi Chemical Advanced Therapeutics Solutions
    David Smith leads the Innovation & Engineering Center at Hitachi Chemical Advanced Therapeutics Solutions’ with the drive to develop, evaluate and provide novel technology solutions in order to realize commercial success of cell therapies. Before joining the company in 2015, David completed his PhD at Loughborough University establishing Quality by Design principles within cell therapy manufacturing with an interest in Process Analytical Control. Prior to this, David completed a Masters in Biochemical Engineering based at University of Bath, along with extensive periods at UNSW, Australia and DSM, Netherlands. This interdisciplinary background allows David to enhance the robustness and reproducibility of processes whilst analyzing costs and sustainability to supplement Hitachi Chemical Advanced Therapeutics Solutions’ drive to ensure access and deliverability of cell and gene therapies to all.
    24 April 2019
    Innovator Insight
  • Expert Roundtable: Tackling the critical issues pertaining to raw & starting materials for cell & gene therapy manufacturing

    R McFarland,
    Richard McFarland
    Chief Regulatory Officer at Advanced Regenerative Manufacturing Institute
    Richard McFarland, PhD, MD, joined ARMI as its Chief Regulatory Officer in May 2018 having been at the Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA/CBER) where his career of over 16 years involved review of an extensive range of products and policy development in numerous areas inside FDA, across the federal government, and internationally. He spent almost two decades at the FDA, including time as Associate Director of Policy for FDA/CBER’s Office of Tissues and Advanced Therapies (OTAT), and its predecessor office, the Office of Cellular, Tissue and Gene Therapies (OCTGT).
    I Kljavin,
    Ivar Kljavin
    Head of Quality, Bioproduction Division at Thermo Fisher Scientific
    Ivar joined Thermo Fisher in January 2018 having spent 24 years in the pharmaceutical industry with Roche – five years in research and the rest in Global Quality roles, QC/QA. What drew him to the Thermo Fisher role is the opportunity to influence the future state of supply of medicine to patients. Ivar is passionate about the transition of Thermo Fisher’s quality system – and the need to integrate Quality process and goals with customers so that we are aligned with the mission of insuring supply of medicine to patients. Thermo Fisher definitely has the capability to make this happen.
    T Moore
    Timothy Moore
    Tim Moore has more than three decades of leadership experience in biopharmaceutical manufacturing and operations. Most recently, he served as Senior Vice President, Head of Global Technical Operations – Biologics of Genentech, Inc. and as a member of the Genentech Executive Committee since 2010. In this role, Mr. Moore oversaw global leadership for more than 7,500 professionals across 10 internal sites and over 37 contract manufacturing organizations, as well as global manufacturing and end-to-end quality supply performance of more than 20 biological product families. Prior to that, Mr. Moore was Genentech’s Senior Vice President, Global Supply Chain and Global Engineering from 2007 to 2010. Previously, Mr. Moore served as Vice President, Operations at ZLB Behring (formerly Aventis Behring). He is currently a member of the Executive Committee of BioPhorum Operations Group (BPOG) and the Manufacturing Leadership Council. Mr. Moore received a B.S. in Chemical Engineering from Tulsa University and a M.S. in Engineering Management from Northwestern University.
    15 April 2019
    Expert Roundtable Video
  • Making an efficient & effective transition to GMP raw materials

    U Nirenberg
    Udo Nirenberg
    Head, Quality Management at CellGenix GmbH
    Dr Udo Nirenberg is Vice President of Quality Management at CellGenix, where he is responsible for the quality system of CellGenix and the quality of the products. Udo has more than 25 years experience in the industry in leading positions in Quality Control, Quality Assurance as well as Regulatory Affairs. Udo holds a degree in chemistry and received his Ph.D. in analytical chemistry from the University of Frankfurt/Main, Germany. He started his carreear at Bachem, Switzerland, a leading GMP manufacturerer of peptides. In the following years he took over the responsibilities for quality control, quality assurance and regulatory affairs departments at Bachem affiliates in the United States. Prior to his position at CellGenix, Udo was responsible for quality control testing of biopharmaceuticals under GMP and quality management for more than 10 years at Solvias AG, a globally acting analytical contract laboratory in Switzerland. Quality Management at CellGenix, where he is responsible for the quality system of CellGenix and the quality of the products. Udo has more than 25 years experience in the industry in leading positions in Quality Control, Quality Assurance as well as Regulatory Affairs. Udo holds a degree in chemistry and received his Ph.D. in analytical chemistry from the University of Frankfurt/Main, Germany. He started his carreear at Bachem, Switzerland, a leading GMP manufacturerer of peptides. In the following years he took over the responsibilities for quality control, quality assurance and regulatory affairs departments at Bachem affiliates in the United States. Prior to his position at CellGenix, Udo was responsible for quality control testing of biopharmaceuticals under GMP and quality management for more than 10 years at Solvias AG, a globally acting analytical contract laboratory in Switzerland.
    9 April 2019
    Podcast
  • Raw and Starting Materials – Foreword

    R Piperno
    Robert G Piperno
    Robert G Piperno is the Director of CGT Quality Assurance in the Global Pharma QA organization. In this role he is responsible for providing the global quality oversight and management of internal and external activities supporting clinical and commercial Cell and Gene Therapy Products, including the approval of STRIMVELIS™ by EMA. Rob joined GSK in 2009 as part of the Corporate Audit and Assurance function and transitioned to R&D QA in 2012, and to CGT QA in 2014. He has over 20 years of experience in the pharmaceutical industry and prior to GSK he was employed at Johnson & Johnson for 9 years holding positions including, site quality operations and leading a corporate team supporting the management of external partners and CMOs. Rob has a Bachelor’s and Master’s degree in Biology from Rutgers University and an MBA in Pharmaceutical Management from St. Joseph’s University.
    1 April 2019
    Foreword
  • How to effectively manage critical raw materials to support clinical development in CAR-T cell therapy

    E Gauthy,
    Emilie Gauthy
    Industrialization Manager
    Emilie Gauthy is Industrialization Manager at Celyad Oncology and a Bioengineer by training with a PhD in immunology. In her role at Celyad, Emilie oversees CMOs & CROs work and acts as the Raw and Starting Materials Site Matter Expert in the context of autologous and allogeneic CAR-T manufacturing.
    L Lambricht,
    Laure Lambricht
    QA Associate at Celyad SA
    S Snykers
    Sarah Snykers
    QC Manager at Celyad SA
    Sarah is Director of the Cell Therapy Manufacturing Unit at Celyad, a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer. She has over 10 years of experience in cell therapy, biomedical research, development and quality control.She is a pharmacist from education and has a PhD in pharmaceutical and biomedical sciences, specialised in stem cell biology. In 2010, she joined Promethera BioSciences, a biopharmaceutical company dedicated to the development of cell therapy products based on allogeneic adult stem cell technology to treat liver diseases. She headed the R&D, QC and Preclinical Departments. In 2015, she joined Celyad. Sarah initially led the immune-oncology program at R&D level, focused on technology transfer, product characterization and optimization. In 2016, she became Head of the QC Department, covering release of clinical products and raw material, analytical method development and translational research activities. In 2020, all operational activities including Production, QC, Validation and Tech transfer of processes, methods, equipment, raw material and viral vector became under her responsibility.
    28 March 2019
    Perspective
  • Raw materials in cell therapy: start right early in process development

    A Gilbert
    Anna Gilbert
    Director, BioProcess Technology at BDO
    Anna Gilbert has over 20 years of experience in Quality Assurance in Biotechnology, with the last 8 years focused in cell therapy. Anna is currently the Director of Quality at Nohla Therapeutics, Inc. Prior to Nohla, Anna has prior experience at several biotech companies. Most recently she started in January 2014 at Juno Therapeutics as one of the earliest employees and the first in Quality Assurance. She established the first quality systems for Juno and managed the GMP quality compliance program. At Dendreon, Anna managed all aspects of GMP and GTP quality compliance, including internal and external auditing as well as compliance oversight of apheresis sites. She joined Dendreon in 2009 and participated in the successful pre-approval inspection of the first US commercial cell therapy, Provenge. Anna is an ASQ Certified Quality Auditor and a member of the Parenteral Drug Association (PDA). She delivers an annual lecture on the topic of GMP auditing at University of Washington’s Master of Science in Biomedical Regulatory Affairs program.
    28 March 2019
    Expert Insight
  • Raw and starting material considerations for gamma delta T cell therapy

    S Abbot
    Stewart Abbot
    CSO at Adicet Bio
    Stewart Abbot is the chief operating officer at Adicet Bio. He holds a BSc in Biological Sciences (Edinburgh), M.Sc. in Biomedical Engineering (Glasgow) and Ph.D. in Pathology (London). His academic career focused on basic and translational science initiatives in vascular biology, pharmacology and toxicology. He joined Amersham Biosciences in 2000 and developed Amersham’s and, following acquisition, General Electric’s stem cell-based drug screening capabilities. He was head of the Molecular and Cellular Biology research laboratory at GE’s Global Research Center from 2004-2007. In 2007 he joined Celgene to develop novel cell-based therapeutic candidates and subsequently development of external cellular therapy R&D collaborations and alliances. In 2015 he joined Fate Therapeutics and held roles of VP translational research and chief development officer. He joined Adicet Bio. in June 2018 and his current role oversees all research and development associated with genetically engineered gamma delta T cell-based therapy development.
    28 March 2019
    Interview
  • Can iPSCs Address the Challenge of Maintaining Consistent Quality in Starting Materials Used in the Manufacture of Cell-Based Therapies?

    K Kelly
    Kilian Kelly
    Vice President, Product Development at Cynata Therapeutics Ltd
    28 March 2019
    Expert Insight
  • Identifying Critical Quality Attributes of cellular starting materials

    D Roy
    Dr. Krishnendu Roy
    Dr. Krishnendu (Krish) Roy received his undergraduate degree from the Indian Institute of Technology (Kharagpur, India) followed by his MS from Boston University and his PhD in Biomedical Engineering from Johns Hopkins University. After working for 2 years at Zycos Inc., a start-up biotechnology company, Dr. Roy left his industrial position to join the Biomedical Engineering Faculty at The University of Texas at Austin in 2002, where he was most recently Professor and Fellow of the Cockrell Chair in Engineering Excellence. He left UT-Austin in July of 2013 to move to Georgia Tech. where he is now the Robert A. Milton Chaired Professor in Biomedical Engineering. At Georgia Tech, he also serves as the Director of the newly established NSF Engineering Research Center (ERC) for Cell Manufacturing Technologies (CMaT) and The Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M) – as well as the Director of the Center for ImmunoEngineering. He is also the Technical Lead of the NIST/AMTech National Cell Manufacturing Consortium (NCMC), a national public-private partnership, focused on addressing the challenges and solutions for large scale manufacturing of therapeutic cells. Dr. Roy’s research interests are in the areas of scalable cell manufacturing, Immuno-engineering, stem-cell engineering and controlled drug and vaccine delivery technologies, with particular focus in biomedical materials. In recognition of his seminal contributions to these fields, Dr. Roy has been elected Fellow of the American Institute for Medical and Biological Engineering (AIMBE) and Fellow of the Biomedical Engineering Society (BMES). In addition, Dr. Roy has received numerous awards and honors including Young Investigator Awards from both the Controlled Release Society (CRS) and The Society for Biomaterials (SFB), NSF CAREER award, Global Indus Technovator Award from MIT, the CRS Cygnus Award etc. He is also the recipient of Best Teacher Award given by the Biomedical Engineering Students at UT-Austin and the best advisor award given by bioengineering students at Georgia Tech. He serves as a member of the Editorial Boards of the Journal of Controlled Release, the European Journal of Pharmaceutics and Biopharmaceutics, and the Journal of Immunology and Regenerative Medicine. He is a member of the Forum on Regenerative Medicine of the National Academies of Science, Engineering and Medicine (NASEM) and a Board Member of the newly established Standards Coordinating Body (SCB) for Cell and Regenerative Therapies.
    28 March 2019
    Interview
  • Staying ahead of the game: understanding and managing patient-to-patient variability

    J Melenhorst
    Jos Melenhorst
    Director, Product Development & Correlative Sciences Laboratory at University of Pennsylvania
    Dr Jan Joseph (Jos) Melenhorst obtained his PhD at the LUMC (Department of Hematology) on the pathogenesis of Aplastic Anemia. In 1998 he moved to Bethesda, Maryland, where he did his research - first as a postdoc, later as a staff scientist - in the laboratory of Dr. John Barrett at the National Institutes of Health, on the immunobiology of marrow failure syndromes, leukemic disorders, and allogeneic stem cell transplantation. In 2012 he was recruited by Dr. Bruce Levine and Dr. Carl June to the University of Pennsylvania, first as Deputy Director of their clinical manufacturing (cGMP) facility. After a year he was promoted to Director of Product Development & Correlative Sciences. In this role, he was at the cusp of the first ever CAR T cell therapy approved by FDA: Kymriah. Dr. Melenhorst is interested in understanding and improving the anti-tumor efficacy and safety of adoptively transferred chimeric antigen receptor-modified T cells through correlative, mechanistic, and functional genomics approaches.
    28 March 2019
    Interview
  • Genomic-QC: large-scale genomic data mining to assess the quality of HiPSC lines

    R More,
    Ravi Prabhkar More
    M Rao,
    Mahendra Rao
    Scientific Co-founder, Chief Strategy Officer at Q Therapeutics
    O Mukherjee
    Odity Mukherjee
    Investigator at National Center for Biological Sciences
    28 March 2019
    Research Article
  • Qualification of cellular starting materials for cell-based therapies

    E Read
    Elizabeth Read
    Principal Consultant at EJ Read Consulting LLC
    Elizabeth Read, MD is an independent consultant focusing on CMC development and CMC regulatory issues for cell- and tissue-based therapies. Dr. Read received her M.D. from the State University of New York (Buffalo, NY). After clinical training in Internal Medicine, Hematology, Oncology, and Blood Banking/Transfusion Medicine, Dr. Read worked at the National Cancer Institute and later in the Clinical Center’s Department of Transfusion Medicine at the National Institutes of Health (NIH; Bethesda, MD), where she served as Section Chief and Medical Director of the Cell Therapy Core Facility from 1995-2006. Initially engaged with novel cellular therapies in the context of hematopoietic transplantation, she later worked on more complex cell, tissue, and gene therapies for a range of clinical indications. From 2007-2010, she headed the Cell Therapy Program at Blood Systems Research Institute (San Francisco, CA), collaborating with UCSF investigators on grant-funded stem cell projects. She previously served as Medical Director at the American Red Cross Blood & Tissue Services (Los Angeles, CA). Over the past 10 years, she held leadership positions at small biotech companies, including Fate Therapeutics (San Diego, CA), StemCyte (Baldwin Park, CA), Medeor Therapeutics (San Mateo, CA), and Adicet Bio (Menlo Park, CA). Dr. Read has authored over 100 scientific publications, and has served as a faculty lecturer at UCSF and for the American Course on Drug Development and Regulatory Science. She has served on advisory committees focused on quality, safety, and efficacy of blood products and cell, tissue, and gene therapies, including the American Association of Blood Banks, the US DHHS/HRSA Advisory Council for Blood Stem Cell Transplantation, and the US Pharmacopeia. She currently serves as an advisor on clinical-stage cell therapy projects funded by the California Institute of Regenerative Medicine.
    28 March 2019
    Expert Insight
  • Planning for success: emerging GMP-grade raw materials & technologies for cell therapy

    Planning for success: emerging GMP-grade raw materials & technologies for cell therapy

    Sean Kevlahan
    Sean Kevlahan, Senior Director, Cell & Gene Therapy at Bio-Techne - R&D Systems
    Lisa Fox
    Lisa Fox, Co-Founder at Broken Lance Biotech Consulting
    Angel Herrero
    Angel Herrero, Pharmaceutical Development Head at Takeda Pharmaceutical Company Limited
    Marketa Horalkova
    Marketa Horalkova, Supply Chain Manager at SOTIO a.s
    Patrick Ginty
    Patrick Ginty, Head of Regulatory Affairs at Cell and Gene Therapy Catapult
    27 March 2019
    Webinar
  • Critical components for developing and managing expansive, high-performing collection networks

    Critical components for developing and managing expansive, high-performing collection networks

    Amy Hines
    Amy Hines, Senior Manager, Network Development at Be The Match BioTherapies
    Richard Smith
    Richard Smith, Consultant, Cell Therapy at Be The Match BioTherapies
    Joseph Vitale
    Joseph Vitale, Director, Account Management at Hitachi Chemical Advanced Therapeutics Solutions
    Sanjin Zvonic
    Sanjin Zvonic
    14 March 2019
    Webinar
  • Designing GMP-friendly cell and gene therapy manufacturing processes

    Designing GMP-friendly cell and gene therapy manufacturing processes

    Michael Papadimitrious
    Michael Papadimitrious, Product Manager at Miltenyi Biotec
    Xiuyan Wang
    Xiuyan Wang, Assistant Director, Michael G. Harris Cell Therapy & Cell Engineering Facility at Memorial Sloan-Kettering Cancer Center
    Brian Murphy
    Brian Murphy, Director, Bioprocess Development at Celgene Corporation
    6 March 2019
    Webinar
  • Managing starting material stability to maximize manufacturing flexibility and downstream efficiency

    Managing starting material stability to maximize manufacturing flexibility and downstream efficiency

    Dominic Clarke
    Dominic Clarke, Global Head of Cell Therapy at HemaCare Corporation
    David Smith
    David Smith, Senior Biomedical Engineer at Hitachi Chemical Advanced Therapeutics Solutions
    21 February 2019
    Webinar